DAIICHI, LILLY COMPLETE ENROLLMENT IN TRIAL COMPARING PRASUGREL, PLAVIX

Daiichi Sankyo and Eli Lilly have announced the completion of patient enrollment in their pivotal Phase III head-to-head clinical study, TRITON TIMI-38, to evaluate the safety and efficacy of prasugrel compared with Plavix (clopidogrel) in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI).

The Phase III study is designed to evaluate the safety and efficacy of prasugrel compared with clopidogrel in reducing ischemic events such as heart attacks, stroke and death in patients with acute coronary syndrome undergoing PCI, a procedure to open blockages in heart arteries that includes the use of coronary stents. Patient enrollment began in November 2004 and has reached a total enrollment of 13,614 patients at more than 700 trial sites in 30 countries. In the United States, more than 4,063 patients have been enrolled at 313 trial sites, and in Europe, 2,178 patients have been enrolled at 132 sites.

Antiplatelet agents are used both acutely and as maintenance therapy to inhibit platelet activation and subsequent aggregation that occur in diseased arteries and in response to invasive procedures such as PCI. Antiplatelet agents prevent platelets from clumping or sticking together, which can cause formation of blood clots and lead to heart attack or stroke. Recent studies suggest that a relationship may exist between a poor platelet response to antiplatelet agents in individual patients and poor clinical outcomes, which can manifest as major adverse cardiovascular events, including heart attacks, according to the companies.

Eli Lilly and Sankyo, a subsidiary of Daiichi Sankyo, are co-developing prasugrel. The drug is designed to inhibit platelet activation and aggregation by blocking the P2Y12 adenosine diphosphate receptor on the platelet surface.